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510(k) Data Aggregation

    K Number
    K030185
    Device Name
    ENDOS AC/ACP
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2003-03-11

    (49 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K984524
    Why did this record match?
    Device Name :

    ENDOS AC/ACP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

    Device Description

    ENDOS AC – ENDOS ACP intraoral system

    AI/ML Overview

    This document is a 510(k) summary for the ENDOS AC – ENDOS ACP intraoral system, seeking substantial equivalence to the AZTECH 70 model. The submission focuses on comparing technical specifications rather than clinical performance based on specific acceptance criteria and detailed study results. Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment are not present in the provided text.

    Here is an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, the AZTECH 70. This largely involves matching or exceeding its technical specifications and intended use. The table below outlines the key comparative elements provided in the document.

    Acceptance Criteria Focus (Implicit)Predicate Device (Aztech 70) PerformanceSubject Device (ENDOS AC-ACP) PerformanceDevice Meets Acceptance Criteria? (Based on Substantial Equivalence Claim)
    Intended Useextra oral source X-ray system for dental radiographic examination of the teethextra oral source X-ray system for dental radiographic examination of the teethMet: Identical intended use.
    High Voltage Value70 kV70 kVMet: Identical.
    Tube Current8 mA8 mAMet: Identical.
    X-ray Tube InsertCEI OCX 70-GCEI OCX 70-GMet: Identical.
    Focal Spot Size0.8 mm (IEC 336)0.8 mm (IEC 336)Met: Identical.
    H.V. TypeSingle phase, self rectifyingSingle phase, self rectifyingMet: Identical.
    X-Ray Exposure Time ControlMicroprocessor ControlledMicroprocessor ControlledMet: Identical.
    Compensation of Line Voltage FluctuationsYes, automatically by software algorithmYes, automatically by software algorithmMet: Identical.
    Total Filtration> 2.0 mm Al> 2.0 mm AlMet: Identical.
    HVL> 1.5 mm Al> 1.5 mm AlMet: Identical.
    X-Ray Exposure Timing0.040 sec to 3.2 sec0.020 sec to 3.2 secMet: Subject device has a wider range which encompasses and expands upon the predicate.
    Electrical Characteristics120 V +/- 10%, 7.6 impulsive A max120 V +/- 10%, 7.6 impulsive A maxMet: Identical.
    Focus-Film Distance> 20 cm> 20 cmMet: Identical.
    Leakage Radiation
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